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510(k) K850014

HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE by Medi-Dent American, Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1985
Date Received
January 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression Tray, Resin
Device Class
Class I
Regulation Number
872.3670
Review Panel
DE
Submission Type

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  • K905058 — PALAVIT L (June 6, 1991)
  • K902350 — PALATRAY LC RESIN IMPRESSION TRAY MATERIAL (July 26, 1990)
  • K901782 — CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM (June 29, 1990)
  • K890712 — ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS (April 25, 1989)
  • K881838 — MODIFIED PERMAGUM ADHESIVE (July 27, 1988)